This TC IRB blog series, “Fostering Ethical Research in Contexts with Nuanced Vulnerability” presents the three core principles identified in the Belmont Report and explores how to conceptualize these ethical guidelines when conducting research with populations that exhibit nuanced vulnerabilities. In the previous article, “Bearing the Burdens of Research”, we explored how investigators may apply the principle of justice to their research endeavors by engaging in fair recruitment practices, mitigating risks and barriers to participating in research, and introducing flexibility and cultural sensitivity. This article will cover the principle of beneficence, outlined in the Belmont Report, and elucidate why it is essential for investigators to achieve a comprehensive understanding of what well-being means for populations of interest and how to maximize direct and indirect benefits while minimizing risks.   

Foundational Principles in the Belmont Report

Promoting the common good in research possesses an inherent duality that is best encapsulated by the principle of beneficence, which states that the research process should ensure that “persons are treated in an ethical manner not only by respecting their decisions and protecting them from harm, but also by making efforts to secure their well-being” (OHRP, 1979). This principle is concerned with two components:

  1. do no harm (nonmaleficence)
  2. maximize possible benefits and minimize possible harms (maximizing principle)

Applications of “Beneficence”

Fostering beneficence in research, especially research involving marginalized, exploited groups or other populations with nuanced vulnerabilities, requires a joint effort by both investigators and members of the IRB to ensure that research studies optimize the probability and magnitude of benefits to all participants and to the larger society. For instance, participants in clinical trials investigating treatments for a specific disease should reflect the population(s) most affected by the disease or the targeted population. In conjunction with the consideration of benefits, harms (or risks) must also be examined. These may include unpleasant, serious, or even life-threatening side effects. Alternatively, extensive lab visits or dosage schedules in a clinical trial for disease treatment may be time-consuming for participants. This process involves the implementation of a Risk-Benefit Analysis, where the probability of a risk occurring during the research study and the degree of harm is weighed against the anticipated benefits. IRBs conduct this analysis whenever they review a protocol; investigators should demonstrate in the IRB application a refined understanding of the risks and benefits to participants and society. A Risk-Benefit Analysis is executed with the intent of determining whether the indirect or direct benefits experienced by human research subjects justify the probability of undertaking risks that are associated with the research activities. For example, there is a study examining the relationship between personal food choices and mood by having participants without eating disorders complete a confidential 15-minute survey regarding food choices and reported mood states. The benefits are an increase in valuable nutritional knowledge and a nutritional counseling session. The minor emotional risks associated with this study such as embarrassment or fatigue do not outweigh the benefits associated with participating in this research study. 

Securing Participants’ Well-Being

To fully promote beneficence in the research community, well-being must be secured for every research subject. Basic well-being is shared across many groups, such as having robust health and financial stability but it is important to acknowledge cultural distinctions. For instance, in various studies, East Asian cultures have expressed a preference for experiencing low-arousal positive emotions, and have reported sustained attention regarding satisfying social roles, affiliative duties, and relationships, which greatly influence their well-being (Newman, 2019). Whereas, in countries like Australia and the United States, well-being is associated with agency, goal-setting, and fulfillment, individual hedonic experiences, and high-arousal positive emotions (Joshanloo et al., 2021). Therefore, before fostering well-being, investigators should first understand what this concept truly means to their population of interest. This may imply consulting personnel who have lived experiences or have conducted research with these groups. Consequently, this process will entail achieving a thorough understanding of direct and indirect benefits and how they influence populations with nuanced vulnerabilities.

Consideration of Benefits

When thinking about participating in research, direct benefits to participants may be difficult for researchers to identify (or achieve), as they are often associated with a medical intervention subjects would not otherwise receive. Yet, it is important for socio-behavioral investigators to widen the scope of consideration and understand the reasons why participants, specifically those with nuanced vulnerabilities, choose to participate in research studies. Some examples may include outcomes such as the dissemination of knowledge participants would otherwise not have access to, including free technical workshops, business consultations, or education classes. Other examples may include therapeutic benefits or diagnostic benefits such as free neuropsychological testing or mental health screenings received by participating in the study. Education researchers who conduct school-wide studies may consider providing the schools with an official report detailing their aggregated findings, along with recommendations for future improvement. These types of (potential) direct benefits are particularly significant and accepted by populations who may not have facile accessibility, otherwise.

On the other hand, there are indirect benefits that are just as invaluable. There are generally two types: first, collateral benefits, which may be received by just being a study subject, but not necessarily participating in an experimental intervention. These benefits may include free therapy sessions or a school-wide assembly on mental health. Indirect benefits should be considered when engaging in research that does not involve an intervention and so provides limited or no direct benefits. 

Second, there are aspirational benefits, which are incredibly important in uplifting communities and can benefit society at a later time. This may involve addressing the lack of inclusion of marginalized groups in large-scale research, advancing equity in research domains, obtaining data necessary to develop treatment plans for an underserved population, and building trust within underrepresented communities. Indirect benefits should not serve as a replacement for direct benefits; however, students or researchers who lack funding to provide resources or compensation should strive to include indirect benefits on their IRB application. It is also important to note the distinction between compensation and benefits. Compensation is a form of payment or non-monetary reward that is given to participants as a recompense for participating in the research study. Compensation cannot be considered a benefit of research as it serves as a small incentive for completion of the study and elements such as potential undue influence and coercion must be avoided. Whereas, benefits are desired outcomes obtained by participating in research, which may be of use to the participant or society as a whole. 


Investigators and members of the IRB should work jointly to envision a study where benefits are maximized and potential risks are minimized. This process should be preceded by a tailored understanding of what well-being may mean to oppressed groups and other populations with nuanced vulnerabilities and what motivates these populations to participate in research. Investigators should consider structuring research protocols so that research subjects are obtaining the types of benefits they desire and supplying them with the most support. These practices may be instrumental in closing the gap in minority representation in research.